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Cytotec Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cytotec (misoprostol) is used to prevent the formation of ulcers in the stomach during treatment with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs and aspirin are used to treat pain, fever, arthritis, and inflammatory conditions. It is a synthetic (man-made) prostaglandin. This medication is available in generic form. Common side effects include nausea or stomach cramps.
The recommended adult oral dose of Cytotec for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. Cytotec may interact with antacids that contain magnesium. Other drugs may also interact with Cytotec. Tell your doctor all prescription and over-the-counter medications and supplements you use. Cytotec must not be used during pregnancy to prevent stomach ulcers because of possible harm to a fetus. Use birth control while taking Cytotec and for at least one month or one completed menstrual cycle after you stop taking it. This medication passes into breast milk. This drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Our Cytotec (misoprostol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cytotec in Detail - Patient Information: Side Effects
Stop taking misoprostol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These problems usually occur during the first few weeks of treatment and stop after about a week. The occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these symptoms persist for longer than 8 days or if they are severe.
Other, less serious side effects may also occur. Continue to take misoprostol and talk to your doctor if you experience
- headache; or
- menstrual cramps, spotting, or increased or irregular menstruation.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cytotec (Misoprostol)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Cytotec Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Diarrhea is common with misoprostol and usually occurs about two weeks after you start taking it, and lasts for about a week. Be sure to keep up your intake of fluids and minerals/electrolytes to prevent dehydration. Persistent diarrhea may sometimes lead to a large loss of your body's water and minerals. Tell your doctor immediately if you develop any of these serious signs of dehydration and mineral imbalance: severe dizziness, decreased amount of urine, mental/mood changes, muscle weakness, slow/irregular heartbeat.
Tell your doctor immediately if any of these unlikely but serious side effects occur: menstrual problems or irregularities, unusual/heavy vaginal bleeding.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Cytotec (Misoprostol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cytotec FDA Prescribing Information: Side Effects
The following have been reported as adverse events in subjects receiving Cytotec:
In subjects receiving Cytotec 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14-40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13-20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo.
Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of Cytotec (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if Cytotec is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Cytotec with magnesium-containing antacids.
Women who received Cytotec during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to Cytotec administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (See BOXED WARNINGS.)
There were no significant differences in the safety profile of Cytotec in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients.
Additional adverse events which were reported are categorized as follows:
Incidence greater than 1%
In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving Cytotec and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for Cytotec and placebo.
Causal relationship unknown
The following adverse events were infrequently reported. Causal relationships between Cytotec and these events have not been established but cannot be excluded:
Body as a whole: aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes.
Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA).
Hypersensitivity: anaphylactic reaction
Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase.
Read the entire FDA prescribing information for Cytotec (Misoprostol)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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